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Serving up Trouble

Feb 17 2009

When foodborne illness outbreaks occur, the source of the contamination is not always clear. Lawyers pursuing foodborne illness claims must carefully determine the applicable laws and identify the party that brought the product to market.

These days, ready-to-eat produce is more popular than ever. Unfortunately for the American populace, prepackaged produce often carries a risk of harboring foodborne pathogens. Due to large-scale production and distribution, prepackaged produce that is tainted has the potential to affect thousands of consumers. According to the Centers for Disease Control and Prevention (CDC), foodborne illness kills 5,000 people in the United States every year.1

With the advancing sophistication of scientific detection and investigation methods, one can hope that the root causes of food product defects will be easier to identify in the years to come. In the interim, the legal system remains the only avenue of recovery for consumers injured by foodborne diseases.

The United States has seen several foodborne illness outbreaks in recent years, including a 2008 salmonella outbreak linked to raw tomatoes and peppers that sickened 1,442 people in 43 states,2 a 2006 E. coli outbreak that was later linked to Dole brand baby spinach and resulted in 204 confirmed E. coli cases,3 and a 2002 E. coli outbreak linked to ConAgra brand ground beef, in which nearly 19 million pounds of beef were recalled.4 Perhaps the most well-known foodborne illness outbreak in the United States was a 1993 E. coli outbreak associated with the Jack in the Box restaurant chain that left more than 700 people ill and four children dead.5

Every foodborne illness outbreak presents unique circumstances. The 2006 Dole outbreak was notable, however, for the FDA’s success in tracing the source of the contamination to a particular growing area and finding the outbreak strain present there. The Dole outbreak highlights some of the essential steps to conducting food products liability litigation, including determining the applicable body of law, the entities subject to strict liability, the indemnity and insurance issues involved, the role third-party defendants might play, and the extent to which the defendant knew about the risk of contamination.

The outbreak

Official word of the spinach contamination broke on September 14, 2006, with an FDA announcement that numerous E. coli O157:H7 illnesses across the country were potentially “associated with the consumption of produce.”6 The statement noted, “[P]reliminary epidemiological evidence suggests that bagged fresh spinach may be a possible cause of this outbreak.” By the date of the announcement, 50 cases of E. coli illness matching the genetic marker associated with the outbreak had been reported to the CDC. Of those, one had resulted in death and eight in hemolytic uremic syndrome, a disease characterized by the breakdown of red blood cells, a low platelet count, and acute kidney failure.7

The much-publicized outbreak grew substantially over the next several days. Recognizing the lethality of the developing outbreak, the FDA warned on September 15 that people should “not eat fresh spinach or fresh spinach-containing products.”8

Meanwhile, the FDA and the CDC, in conjunction with local and state health agencies, worked feverishly to determine the brand names linked to the outbreak. Early statistical analysis suggested that many brands were implicated, but all were eventually connected to one processing center: Natural Selection Foods in San Juan Bautista, California. In reaction to this evidence, Natural Selection recalled all its spinach products with “use by” dates from August 17 to October 1, 2006.9

Although Dole spinach was just one of many brands initially recalled, subsequent data analysis revealed Dole as the sole source of the outbreak. Early epidemiological evidence had strongly linked Dole to the illnesses, but the FDA found its proverbial smoking gun on September 20. On that date, a bag of Dole baby spinach tested positive for E. coli O157:H7 bearing the same genetic marker as the outbreak strain.

Epidemiological and laboratory evidence had proved the link between Natural Selection and Dole, and it soon revealed that the contaminated spinach was grown at Paicines Ranch in San Benito County, California. More specifically, investigators traced the source of the contaminated spinach to one field on a ranch that had been leased by Mission Organics, a Salinas, California, company.

Once identified as the likely source of the outbreak, Mission Organics became host to droves of health officials who were searching for the specific strain of E. coli associated with the ever-growing number of illnesses. State and federal investigators took hundreds of environmental samples from the 50-acre vicinity of the spinach field, including samples from a nearby cattle pasture and water source.

Investigators also sampled the intestinal lining of feral pigs, known inhabitants of both the nearby cattle pasture and the spinach field. Investigators found tracks from the pigs in the spinach field, as well as broken, run-down fences surrounding the field. Samples from various sources, including the pigs, the water, and cattle feces, all tested positive for the same strain of E. coli that had, by this point, been isolated in more than 200 people around the country.

Ultimately, the FDA confirmed 204 outbreak-related cases, including 104 hospitalizations, 31 cases of hemolytic uremic syndrome, and 3 deaths,10 although the actual number of people affected but whose illnesses went unreported was likely much larger. The litigation that followed provides several insights into products liability litigation generally and food products litigation specifically.

Strict liability

Without question, the single best weapon in the plaintiff’s arsenal in a foodborne illness case is the strict liability claim. It is well established that commercially sold food falls under a strict products liability scheme.11 What varies from state to state, however, is which entities are strictly liable.

Food product litigation differs from other products liability litigation in one key way: With food, you are not typically dealing with a defective design or failure to warn; the cases are straight-up manufacturing defect claims. These are what some would call “pure” strict liability claims, in that the focus is solely on the product and the existence (or not) of a defect (contamination).

Traditional notions of strict products liability stemming from §402A of the Restatement (Second) of Torts apply liability to any commercial seller. The restatement does not specify the seller’s role in the chain of distribution or the extent of a particular seller’s control over the product. But many states operate under statutory schemes, or common law schemes bounded by statute, that limit full application of strict liability to manufacturers.12

For example, the Washington Product Liability Act (WPLA) applies strict liability to manufacturers but leaves non-manufacturing sellers liable only for negligence.13 Other states employ “pass through” statutes that limit the liability of sellers who do not exercise control over a product, so long as the seller can certify the existence of a solvent manufacturer subject to jurisdiction within the forum.14

Because strict products liability statutes and common law vary significantly from state to state, the first step in assessing whether you can bring a strict liability claim against a particular defendant is to determine what law will apply. In many food products liability claims, the product is manufactured in one forum and consumed in another. The injury often occurs in the forum where the product was consumed, but not always.

The applicable conflict-of-law jurisprudence must be examined first. Once you identify the applicable law, you can determine which entities are strictly liable.

In food litigation, you often need to identify which entities in the chain of production and distribution are considered manufacturers. For a processor like Natural Selection Foods, its status as a manufacturer is fairly obvious. But attorneys for growers and packers of fresh fruit and vegetables undoubtedly will question their clients’ status as manufacturers, arguing that their client is a passive conduit in the chain of distribution, in an attempt to absolve their client from strict liability claims.

The Model Uniform Product Liability Act of 1979 defines a manufacturer as “a product seller who designs, produces, makes, fabricates, constructs, or remanufactures the relevant product or component part.”15 Courts have also viewed manufacturing as any process that adds economic value to a product. Some courts have applied a dictionary definition of “produce” as “to give being, form, or shape to” and “to make economically valuable.”16 The latter definition is particularly important in cases concerning products such as uncooked, uncut vegetables, where the ultimate product has undergone few changes from its natural state.

The bagged spinach implicated in the 2006 outbreak was processed and packed by Natural Selection, a corporate entity entirely separate from Dole, under a “co-pack” agreement. Nevertheless, the bags of spinach were conspicuously marked with the Dole brand and logo and did not indicate that any other entity was responsible for the product. People buying the spinach would not have known that any company but Dole was involved in the manufacturing process.

Through the use of either statutory or common-law-based claims of “apparent manufacturing,” an entity like Dole can be held to a strict liability standard, regardless of whether the applicable jurisdiction adheres to the “chain of distribution” rule embodied in §402A. In an apparent-manufacturer claim, the plaintiff argues that the manufacturer standard should be applied to an entity that holds itself out as a manufacturer.

According to the WPLA, for example, the definition of manufacturer includes “a product seller or entity not otherwise a manufacturer that holds itself out as a manufacturer.”17 The WPLA also provides that an entity that sells a product under a “brand” or “trade name” may be held strictly liable as a manufacturer.18

Other jurisdictions have adopted a common law form of this rule.19 Ultimately, any corporation putting its name on a product likely can be held liable as a manufacturer, whatever the corporation’s actual involvement in creating the product.

E. coli O157:H7 outbreaks associated with lettuce and spinach, specifically the “prewashed” and “ready-to-eat” varieties, are by no means a new phenomenon. Since 1995, federal health officials have recognized more than 20 E. coli O157:H7 outbreaks in which spinach or lettuce was the source of illness.

While the ultimate source of the contamination has not been identified definitively, it remains highly likely that the bacteria that contaminated the produce found its way into the fields from some other entity’s land. Food safety authorities have speculated that E. coli O157:H7 may reach spinach and lettuce fields from the agricultural runoff of upstream farms, from contaminated water supplies, and from wild animals migrating across plots of land.

These scenarios raise the possibility of claims against a possessor of land that is found to be the ultimate source of contamination in a neighbor’s product. But a consumer making such a claim successfully seems unlikely. Claims against entities outside the chain of distribution leave the plaintiff without the option to pursue strict liability, limiting such claims solely to negligence principles.

In this scenario, it might prove difficult to establish a duty to an individual consumer. It is more likely that the defendant or manufacturer would bring trespass or nuisance claims against the source of the contamination as third-party claims or in separate actions.

Insurance and indemnity agreements

An arrangement like the co-pack agreement between Dole and Natural Selection may have a far-reaching impact on the potential settlement of products liability claims that consumers bring. Often, such agreements contain both indemnity provisions and insurance and co-insurance requirements.

These provisions are likely to determine the all-important questions of who is going to pay, in what order, and how much. For example, even though Dole could be held strictly liable as an apparent manufacturer, if Natural Selection had agreed to indemnify it, Natural Selection’s insurer might be first in line to fund any settlements.

Such agreements might also give rise to additional claims of breach of warranty by third-party beneficiaries. A third-party beneficiary claim may create liability for an entity that might not be liable under a tort theory. For example, Dole might have been held liable in a state that did not have an apparent-manufacturer doctrine. Similarly, the grower might have been held liable in a state that did not deem growing to be manufacturing for strict liability purposes.

You must seek such agreements through discovery as early as possible. In cases in federal court, such agreements likely would fall under the disclosure requirements of Federal Rule of Civil Procedure 26(a)(1)(D).

Understanding indemnity and insurance agreements is crucial to understanding all liability claims and devising an effective strategy for settlement.

Punitive damages

The potential availability of punitive damages for food products claims, as in other products liability litigation, lies in the industry’s or the individual corporation’s knowledge of the risk. The standard for applying punitive damages in a food products liability case is whether the corporation consciously disregarded a known safety risk. There were many previous outbreaks that gave the leafy greens industry reason to know that a problem existed within the industry even before the E. coli O157:H7 baby spinach outbreak in the fall of 2006.

In October 2003, for example, 17 residents of a California retirement home were sickened and 4 were hospitalized after eating E. coli-contaminated prewashed spinach.20 In the fall of 2003, nearly 20 patrons of a California restaurant chain fell ill after eating salads prepared with bagged, prewashed lettuce;21 and in July 2002, 28 teenage girls fell ill with E. coli at a cheerleading camp after eating prewashed lettuce, leaving several hospitalized and one with lifelong kidney damage.22

The litigation arising out of the 2006 spinach outbreak concluded in late October; none of the cases filed reached a jury. Perhaps acting as an impetus to settlement, the long history of prior outbreaks and unheeded calls to action would likely have established a firm basis for punitive damages awards in a trial setting.

Industry oversight

Industry regulators, most notably the FDA, have repeatedly warned the leafy greens industry that it needed to change. In 1998, the agency issued guidance designed to help growers and packers implement safer manufacturing practices.23 In 2004, the agency issued a letter to the lettuce and tomato industries to “make [them] aware of the Food and Drug Administration’s (FDA’s) concern regarding continuing outbreaks of foodborne illness associated with the consumption of fresh lettuce and fresh tomatoes, and actions [the FDA] recommend[ed] that . . . industries take to enhance the safety of these products.”24

Following an E. coli outbreak linked to Dole lettuce in 2005, the agency stressed its past efforts and present concerns in another letter.25 The agency noted that since 1995, it had identified 18 outbreaks of E. coli O157:H7 associated with fresh or fresh-cut lettuce, resulting in 409 illnesses and two deaths, and that its research indicated that industry practices, including irrigation and field drainage methods, may have led directly to the contamination.

Local and state authorities also play a crucial role in tracking foodborne illness outbreaks. Reportable disease guidelines require health care professionals and laboratories to report certain diseases and conditions to local and state public health agencies. Foodborne pathogens such as salmonella, campylobacter, Listeria monocytogenes, and shiga-toxin-producing E. coli are included in the list of reportable diseases. This passive surveillance system allows public health agencies to monitor disease trends.

When an increase in the incidence of a foodborne pathogen is observed, the agencies take action. Epidemiologists interview ill patients to detect common exposures to the foodborne pathogen. Molecular microbiology analyses such as pulsed field gel electrophoresis and polymerase chain reaction identify patients infected with genetically indistinguishable bacteria or viruses. This epidemiologic and laboratory data is used to support a foodborne illness outbreak. It may be necessary to conduct additional interviews with people who are not ill to determine the specific food vehicle associated with the illness.

The long-term solution for food safety problems lies not with the federal government or the judicial system but with large-scale commercial buyers. Time and time again, the federal government has proved too slow to address lax food safety regulations. Even after hundreds of lawsuits—resulting in decades of litigation—food safety remains an omnipresent consumer health issue.

To reduce the number of foodborne illness outbreaks in the immediate future, and to ensure that foodborne pathogens are eliminated at the source of the problem, commercial buyers must put pressure on growers and distributors to engage in safer food production and handling pro­cesses. At the end of the day, consumers will become increasingly wary of brands and commercial sellers associated with foodborne illness outbreaks. When these sellers fail to demand safe products from their dis­tributors, they jeopardize not only the health and safety of their custom­ers but also their own profitability, by inviting potential lawsuits and huge amounts of negative publicity.

To be sure, consumers cannot, and should not, let the federal government off the hook; they must demand stricter regulations from their elected officials. Nevertheless, the most expedient step in preventing another deadly foodborne illness outbreak like the 2006 Dole spinach outbreak is to push for greater corporate responsibility regarding the oversight of food producers. The lives of American consumers depend on it.

5. See U.S. Dept. of Agric., The 1993 Jack in the Box Restaurant E. coli O157:H7 Outbreak, in Food Safety Innovation in the United States: Evidence from the Meat Industry, Econ. Research Serv. 10 (Apr. 1, 2004), www.ers.usda.gov/Publications/ aer831/aer831d.pdf.